First Approval for a New Immune Checkpoint Inhibitor
The FDA approved cosibelimab-ipdl for certain skin cancers that cannot be treated with surgery or radiation.
The U.S. Food and Drug Administration (FDA) has approved cosibelimab-ipdl (Unloxcyt) for the treatment of adult patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or radiation.
Cosibelimab-ipdl is an immunotherapy called an immune checkpoint inhibitor. It blocks the protein PD-L1, which is sometimes expressed at high levels on cancer cells and prevents the immune system from attacking the tumor. Immune checkpoint inhibitors mask this signal so immune cells can better find and destroy cancer cells. The preclinical characterization of cosibelimab-ipdl was reported at the American Association for Cancer Research (AACR) Annual Meeting 2017.
Two inhibitors of PD-1, PD-L1’s binding partner on immune cells, were previously approved to treat locally advanced or metastatic CSCC: cemiplimab (Libtayo) and pembrolizumab (Keytruda). Cosibelimab-ipdl is the first PD-L1 inhibitor to be approved for this patient population. Compared with PD-1 inhibition, PD-L1 inhibition has been shown to cause fewer high-grade immune-related adverse effects. The current approval is the first FDA approval for cosibelimab-ipdl.
The decision was based on results from the multicenter, multicohort, open-label, phase I Study CK-301-101 clinical trial. Researchers enrolled 109 patients with metastatic or locally advanced CSCC who were not candidates for curative surgery or radiation and treated them with cosibelimab-ipdl.
Overall, 47% of patients with metastatic CSCC and 48% of patients with locally advanced CSCC experienced a response. In these patients, responses lasted a median of 17.7 months for those with locally advanced disease, and the median duration of response was not reached for those with metastatic disease.
The recommended dose of cosibelimab-ipdl is 1,200 mg delivered intravenously every three weeks until disease progression or unacceptable toxicity.
CSCC is one of the most common types of skin cancer. While U.S. national cancer registries do not track cases of CSCC, over one million people in the United States are estimated to be diagnosed with CSCC each year, and around 1.5% to 5.2% of cases are metastatic.
The FDA rendered its decision on December 13, 2024. Check this resource for updated information on all therapeutics regulated by the FDA.
